FDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH U.S. Food and Drug Administration Center for Devices and Radiological Health [Skip navigation]
horizonal rule
Super Search
510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA
CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards
 

 

Adverse Event Report

DEPUY ORTHOPAEDICS, INC. UNKNOWN DEPUY HIP TOTAL HIP REPLACEMENT   back to search results
Device Problems Component(s), worn; Implant, removal of
Event Date 05/13/2004
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Legal papers state pt received a right depuy hip and in 1/93 pt received a left depuy hip. Both hips are alleged to have deteriorated prematurely requiring surgeries and replacement.

 
Manufacturer Narrative

This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NameUNKNOWN DEPUY HIP
Type of DeviceTOTAL HIP REPLACEMENT
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC.
700 orthopaedics drive
warsaw IN 46581 0988
Manufacturer Contact
hans kusserow, mgr.
700 orthopaedic drive
warsaw , IN 46581-0988
(574) 372 -7416
Device Event Key514071
MDR Report Key524943
Event Key498230
Report Number1818910-2004-00370
Device Sequence Number1
Product CodeJDI
Report Source Manufacturer
Source Type Other
Reporter Occupation ATTORNEY
Remedial Action Other
Type of Report Initial
Report Date 05/13/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/14/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/13/2004
Device Ageunknown
Event Location Hospital
Date Manufacturer Received05/13/2004
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device? Unknown
Type of Device Usage Initial

Database last updated on February 28, 2009

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH